The Guardcontrol Trial: Study to Assess if Type 1 Diabetics Can Improve Using the Real-Time Values of Guardian RT

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.

The objective of the study is to determine whether patients with poor glycemic control can improve metabolic control using the real-time values of the Guardian® RT compared to conventional self-monitoring blood glucose finger-sticks.

Condition or disease

Intervention/treatment

Phase

Diabetes Mellitus

Device: Guardian RT

Phase 4

Detailed Description:

Finger-stick based self-testing (SBGM), as well as diagnostic continuous glucose monitoring (CGMS®) allow diabetic patients to find a balance between the two hyper- and hypoglycemic extremes. Nevertheless, there are still patients who fail to achieve good control due to fear of hypoglycemia, or who underestimate post-prandial hyperglycemias.

The Guardian® RT Telemetered Glucose Monitoring System is indicated for continuous or periodic monitoring of real-time interstitial blood glucose values and low/high blood glucose alarms (when pre-set levels are reached) in persons with diabetes mellitus. The glucose values calculated by the device will be used to trigger hypo- and hyperglycemia alerts and will be displayed every 5 minutes. The Guardian® RT stores up to 21 days of data.

The overall primary objective of the study is to determine whether patients with poor glycemic control as evidenced by HbA1c > 8.1% can achieve improved metabolic control using the real-time values of the Guardian® RT compared to conventional self-monitoring blood glucose finger-sticks (control group) after 12 weeks of continuous use.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Patients are on intensive insulin therapy; for multiple daily injections (MDI) patients specifically, be on a schedule of a minimum of 3 injections daily.

Patients on intensive insulin therapy must be on continuous subcutaneous insulin infusion (CSII) or MDI at least 3 months prior to inclusion and should have been receiving diabetes care from the investigator of each centre for the 6 months prior to inclusion.

Patients must be using only insulin analogues or rapid-acting human insulin for their meal boluses.

Patients are willing to undergo all study procedures.

Patients are trained on how to adapt their insulin dose to their meals and are knowledgeable concerning how to calculate and apply corrective insulin boluses post-prandially, as well as on the influence of physical activity and other life style factors on their glycemia.

Patients are willing to participate in a Guardian® RT product training course

Patients understand how to adjust and administer corrective treatment.

Exclusion Criteria:

Patient has hearing problems/is deaf.

Patient has impaired vision/blindness so screen alarms cannot be recognized.

Patient is unwilling or unable to comply with the provisions of the protocol.

Patient has scheduled travel on a plane in the next 3 months.

Patient has scheduled a vacation which will occur between Visit 1 and Visit 2.

Patient is participating in another device or drug study. Subject must have completed the follow-up phase of any previous study at least 30 days prior to enrollment in this trial. The subject may only be enrolled in this study once. Patient has already participated in the Centre Qualification Phase.